FDA product code · Radiology

Tester, Acoustic, Bone Quality

Name: FDA decisions, review times, recalls and adverse event reports for product code NAN
Creator: 510(k) Report

NANClass IIIPMA required1 decision since 20000 recalls

1 FDA decision since 2000. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, radiology panel

Twenty years of NAN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NAN

FDA has decided no NAN device since 2007.

Median 510(k) review, days · NAN

Too few NAN 510(k)s in any year since 2007 to give a median.

Recalls per year · NAN

No recall names NAN since 2007.

Adverse event reports per year · NAN

No MAUDE report names NAN since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — NAN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NAN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Tester, Acoustic, Bone Quality

What has FDA decided in NAN lately?